Coconut Infused Hybrid Personal Lubricant

K180712 · United Consortium · NUC · Jun 6, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180712
• Device Name: Coconut Infused Hybrid Personal Lubricant
• Applicant: United Consortium
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Coconut Infused Hybrid Personal Lubricant is a non-sterile, water-based, semi-viscous personal lubricant; intended for OTC use by consumers to enhance comfort during intimate sexual activity. Applied topically to penile, anal, or vaginal areas. Packaged in PET bottles or laminated pouches. Device functions by providing physical lubrication to reduce friction. Safety and effectiveness established through biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity) and condom compatibility testing per ASTM D7661-10. Benefits include enhanced ease and comfort of sexual activity and supplementation of natural lubrication.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (ISO 10993-5, -10, -11), condom compatibility (ASTM D7661-10), and real-time aging studies (3-year shelf life). All specifications (viscosity, pH, osmolality, antimicrobial effectiveness per USP <51>, microbial limits per USP <61>/<1111>, and pathogen absence per USP <62>) met acceptance criteria.

Technological Characteristics

Water-based, semi-viscous cream. Ingredients: Water, Propylene Glycol, Caprylic/Capric Triglyceride, Coconut Oil, Flavor, Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Radish Seed Extract, Polyisobutene, Polysorbate 20, PEG-45M. Viscosity: 20,000-31,000 cps; pH: 5.7-6.30; Osmolality: 450-900 mOsm/kg. Non-sterile. Packaging: PET bottles or polyester-faced laminated pouches. Tested per ASTM D7661-10 for condom compatibility.

Indications for Use

Indicated for individuals requiring lubrication and moisturization during penile, anal, and/or vaginal sexual activity to enhance comfort and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Predicate Devices

• Gun Oil H2O water-based lubricant (K152918)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 6, 2018

United Consortium Stephanie Morris Regulatory Specialist 29000 North Hancock Parkway Valencia, CA 91355

Re: K180712

Trade/Device Name: Coconut Infused Hybrid Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 16, 2018 Received: March 19, 2018

Dear Stephanie Morris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180712

Device Name

Coconut Infused Hybrid Personal Lubricant

Indications for Use (Describe)

Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> <span>Residential (Part 24 CFR 982 Subpart D)</span> | <input checked="" type="checkbox"/> <span>Homeownership (Part 24 CFR 982 Subpart O)</span> |
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| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# K180712 - Coconut Infused Hybrid Personal Lubricant

## K180712 - 510(k) Summary

| 510(k) Owner: | United Consortium | |
|---------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Street Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 | |
| Contact Person: | Stephanie Morris<br>Regulatory Specialist | |
| | Bruce Albert<br>Head of Technical Services | |
| Contact Numbers: | Phone: [phone], ext. 232<br>Phone: [phone], ext. 231<br>FAX: [phone] | |
| Summary Preparation Date: | June 5, 2018 | |
| Trade Name: | Coconut Infused Hybrid Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Device Classification: | RegulationName:<br>RegulationNumber:<br>Product Code:<br>Device Class: | Condom<br>21 CFR § 884.5300 (Condom)<br>NUC (lubricant, personal)<br>Class II |
| Predicate Device: | Product Name:<br>510(k) Number:<br>Manufacturer:<br>Product Code:<br>Device Class: | Gun Oil H2O water-based lubricant<br>K152918<br>Empowered Products, Inc.<br>NUC<br>Class II |

The predicate device has not been subject to a design-related recall.

#### Device Description:

Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms.

This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1

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Image /page/4/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" formed by two curved lines. The left line is a dark blue color, while the right line is a light gray color. Below the "U" is the text "UNITED CONSORTIUM" in a sans-serif font. The word "UNITED" is stacked above the word "CONSORTIUM".

# K180712 - Coconut Infused Hybrid Personal Lubricant

oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.

The device specifications are listed in the table below:

| Property | Specification |
|-----------------------------------------------------------------|-----------------------------------------------------------|
| Appearance | Translucent, semi-viscous cream |
| Color | White to off-white |
| Odor | Odorless |
| Viscosity (cps) | 20,000 cps to 31,000 cps |
| pH | 5.7 to 6.30 |
| Specific Gravity | 0.930 to 1.010 |
| Osmolality | 450 to 900 mOsm/kg |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61><br>and <1111> | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP <61><br>and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida Albicans | Absent |

#### Table 1: Device Specifications for Coconut Infused Hybrid Personal Lubricant

## Indications for Use:

Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

## Predicate Device Comparison:

The table below lists the comparative indication for use and technological characteristics of the subject and predicate devices.

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| Feature | Coconut Infused Hybrid Personal<br>Lubricant | Gun Oil H2O water-based lubricant<br>(K152918) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indication for Use | Coconut Infused Hybrid Personal<br>Lubricant is a water-based personal<br>lubricant for penile, anal and/or<br>vaginal application, intended to<br>lubricate and moisturize, to enhance<br>the ease and comfort of intimate<br>sexual activity and supplement the<br>body's natural lubrication. This<br>product is compatible with natural<br>rubber latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | Gun Oil H2O water-based is a<br>personal lubricant intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity. This<br>product is compatible with<br>polyisoprene condoms. This product<br>is not compatible with polyurethane<br>or natural rubber latex condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propylene Glycol,<br>Caprylic/Capric Triglyceride, Cocos<br>Nucifera (Coconut) Oil, Flavor<br>(Aroma), Phenoxyethanol,<br>Polyacrylate 13, Cellulose Gum<br>(sodium carboxymethylcellulose),<br>Raphanus Sativus (Radish) Seed<br>Extract, Polyisobutene, Polysorbate<br>20, PEG-45M | Purified Water, Propylene Glycol,<br>Hydroxyethlcellulose, Aloe<br>Barbadensis Leaf, Potassium<br>Sorbat), Tetrasodium EDTA, Panax<br>Ginseng Root, Paulina Cupana,<br>Avena Sativa, Polysorbate 20, PEG-<br>45, Polyquarternium-5, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |

#### Table 2: Comparator Table for Subject Device – Coconut Infused Hybrid Personal Lubricant and Predicate Device Gun Oil H2O water-based lubricant

The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate device have different technological characteristics, including different formulations and condom compatibility. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

## Summary of Performance Data:

## Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing, were performed in

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# K180712 - Coconut Infused Hybrid Personal Lubricant

accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)

The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

## Shelf-Life:

The subject device device, Coconut Infused Hybrid Personal Lubricant, is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.

#### Condom Compatibility:

The compatibility of the subject device, Coconut Infused Hybrid Personal Lubricant, with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that that the Coconut Infused Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.

#### Conclusion:

The results of the performance testing described above demonstrate that the Coconut Infused Hybrid Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.